Authorities and institutions involved in the immunization process have in some cases failed to demonstrate responsibility for the effective achievement of the objectives of the National Anti-COVID-19 Immunization Plan, and have not fully ensured the achievement of the goal of achieving collective immunity.
The results of the Performance Audit "Have the competent authorities taken sufficient measures to provide citizens with vaccines and to achieve collective immunity to combat COVID-19 infection?" were examined by the Court of Accounts of the Republic of Moldova (CoARM), on December 16 this year.
The purpose of the audit was to assess the implementation of state policies in the field and the activities of the responsible authorities in order to provide citizens with vaccines and achieve collective immunity to combat COVID-19 infection. The audit of the management of the vaccination process made it possible to identify deficiencies in the system and areas for improvement and consolidation, by ensuring compliance with the principles of performance. The audit was performed at the Ministry of Health, the National Agency for Public Health, the Center for Centralized Public Procurement in Health, the Office for the Management of External Assistance Programs and 13 public medical institutions with 89 subdivisions.
The coronavirus pandemic is the defining global health crisis of our time and one of the biggest challenges of the last decades. The development of safe and effective COVID-19 vaccines has been a major step in the global effort to end the pandemic and return to a normal life, and the efforts of all authorities have focused on providing citizens with COVID-19 vaccines in useful terms. The competent authorities of the Republic of Moldova have developed actions and activities aimed at providing citizens with anti-COVID vaccines and have prioritized access to vaccination for certain high-risk population groups.
Currently, our country has received free of charge about 75% of the available vaccines worth 188.3 million lei, and through purchases - 25%. Vaccines were procured with available sources in the state budget, government emergency funds, compulsory health insurance funds, as well as through bilateral agreements with producers or international partners.
Until November 30, our country received about 2 million doses of vaccine and more than 1.6 million doses were administered, vaccine coverage being at a level of 27% of the population of the Republic of Moldova. Recently, there has been a downward trend in the number of administered doses and the vaccinated population, respectively, the highest level being reached during June and July. In the following months, there is a significant decrease, so that in October 121 thousand doses were administered, and in November only 98 thousand doses of COVID-19 vaccine, which indicates a decrease of 31%.
With regard to the record of the distribution of doses of COVID-19 vaccines, it was mentioned that the deliveries from the warehouse of the National Agency for Public Health to the regional Public Health Centers are accompanied by order invoices and from the regional Public Health Centers to the territorial ones subsequently to the Medical Institutions are accompanied by tax invoices. In this context, the audit revealed that the primary documents related to the distribution of doses to the medical institutions do not contain complete information on the batch, the series of vaccines and the expiry date. These circumstances do not provide assurance on the monitoring of the shelf life and lead to the admission of errors in the systemic and complex allocation process. In this way, were created the premises for the erroneous reflection of the distribution and record of vaccines by type and, respectively, the effective achievement of the objectives of the vaccination process is not achieved.
The audit also found that records of vaccine stocks at 50% of the audited entities are kept only in value and settled at the end of the month, based on invoices, for the amount received during the month and not according to their use. Thus, there is a mismatch between the actual existing stocks and the vaccine evidence data.
A non-current regulatory framework that does not meet the requirements for the record of COVID-19 vaccines governs the calculation of the loss factor for vaccine doses. The audit found that from the outset no separate procedures were established to record the loss of vaccine doses, based on the multitude of types received by the Republic of Moldova. It is mentioned that in our country are administered 6 types of anti-covid-19 vaccines, which are packaged differently: single dose, 5 doses, 6 doses and 10 doses. Since the beginning of the vaccination campaign, the number of doses extracted from the Astra Zeneca vaccine bottle has varied from 11-12 doses, and no vaccine losses were allowed, and with the receipt of large quantities as well, in order not to refuse vaccination due to lack of sufficient number of people to allow the full use of vaccines, the authorities have allowed the use of at least one dose of vaccine in the bottle, and losses are allowed up to 80-90%. Thus, the lack of separate procedures for recording and calculating the loss factor of COVID-19 vaccines creates uncertainty about the actual number of doses administered and the doses that were not used, affecting the principle of economy.
With reference to the stages of the vaccination process, it is noted that the National Immunization Plan against COVID-19, exhaustively specifies 3 stages of this process, priority being given to workers in health care institutions, regardless of ownership and legal form of organization. The audit found that in the case of more than 2,500 vaccinated people, the medical institutions did not follow these steps. Thus, access was not prioritized for certain target population groups, especially medical staff.
The audit found that about 7,000 doses of the vaccine had expired, which raises suspicions about their use. At the same time, the audited entities did not present relevant evidence to justify the admitted errors. Therefore, the mismanagement and the inadequacy of key controls in the immunization process have led to the admission of these errors, which can have an impact on the health of citizens.
Regarding the introduction of vaccination information in the Vaccine Registry of COVID-19, the audit team evaluated over 277 thousand vaccination information that was entered in periods other than the actual ones. The analysis, in view of the identified risks, determined that over 70,000 records create suspicions regarding the veracity of the certificates issued by the institutions involved in the process.
At the same time, there is a lack of key controls when entering data in the Vaccination Record Registry and artificial intelligence filters. This system also does not contain approved documents related to its functionality and guidance to its users. These circumstances do not ensure that registration, management and access processes are simple, efficient, secure, accessible and transparent - principles set out in the regulatory framework.
The access of persons authorized to carry out data on vaccinated persons within the audited entities shall be carried out by internal designation orders for 155 registrars. At the same time, the audit shows that 20 registrars, or 12% of them, made registrations in the absence of approval by the managers of medical institutions. Thus, the lack of a comprehensive regulatory framework for authorizing access to the Vaccine Record Registry further maintains the risk of unauthorized access to information.
Vaccine procurement procedures have been organized and conducted based on the principles of efficacy; however, the process of their use indicates non-compliance. Thus, in order not to refuse vaccination due to the lack of a sufficient number of people that would allow the full use of vaccine doses in vials, it was allowed to use at least one dose of vaccine in the vial. At the same time, the audit shows that insufficient vaccine dose planning was not correlated with actual phased needs and led to the formation of vaccine stocks, including expired and subsequent destruction of doses due to non-use. Thus, until November 15, over 11 thousand doses of vaccines worth 1.6 million lei were lost as a result of the expiration of the term.
According to the audit, the difficulties faced by public entities during the pandemic period in managing the COVID-19 vaccination process were largely caused by:
- the novelty of the situation, lack of practices and regulations in managing a complex process in a crisis situation;
- fragmented inter-sectoral communication of stakeholders;
- low responsibility of decision-making management;
- the inadequacy of key controls at all stages of the vaccination process, as well as reduced measures to monitor and supervise the implementation of the actions taken;
- the imperfection of the information system does not fully ensure the evidence and facilitate the vaccination process, etc.
We note that, as a result of the audit activities, there were made recommendations to improve the process, and some institutions, during the audit, took action to remedy the situation and implement the recommendations submitted by the Court of Accounts.